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Susan Haigney is lead editor of BioPharm International®.
June 27, 2023
The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.
June 02, 2023
All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities.
May 18, 2023
The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.
The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
May 17, 2023
The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.
The agency has published guidance on good practices for securing the supply of medicines.